Response rate, TTP, and overall survival were superior for LV-containing regimens compared with IFN modulation alone. The addition of IFN to high-dose infusional FU plus LV offers no advantage and may increase toxicity. The regimen of high-dose infusional FU24h/LV warrants further evaluation in patients with metastatic colorectal cancer.

This interim analysis allows the conclusion that infusional 5-FU plus FA/IFN is no more active than infusional 5-FU plus FA alone. However, 5-FU/FA/IFN despite 5-FU dose reduction was associated with unacceptably high toxicity, including 10% deaths. Therefore, further investigation of this regimen is not justified. The study is continued with the comparison of 5-FU/FA vs. 5-FU/IFN.

Pathological alterations of the ductal system found during ERCP in 1082 examinations were due to pancreatic carcinoma in 54 patients. The diagnosis was confirmed by laparotomy or autopsy. Predominant findings in 42 patients were stenoses, prestenotic dilatation, caliber variation, stop of contrast medium and ductal displacement in pancreatography. In 28 cholangiograms stenoses were most common which were localized in one third of the cases in the proximal common bile duct. Four types may be differentiated: a stenosing type, an obstructed type, a tapering type and a cavernous type. The stenosing type can be divided in a form with and without interruption of the contrast medium column. A precise differential diagnosis between pancreatic carcinoma and chronic pancreatitis is not possible but a long stenosis with or without stop of the contrast medium speaks in favour of a tumorous process.

No abstract

Biochemical modulation of 5-fluorouracil (5-FU) by folinic acid (FA) increases the response rate in patients with metastatic colorectal cancer compared to 5-FU alone. Phase II trials also demonstrated increased efficacy when interferon was added to 5-FU. In two consecutive trials, 76 patients were treated on days 1-5 with FA 200 mg/m² plus interferon 5 × 10⁶ U/m² and 5-FU 350 mg/m² as intravenous bolus injection (n = 33, regimen A) or 5-FU 500 mg/m² as 2-hour infusion (n = 43, regimen B), repeated every 3 weeks with individual 5-FU dose escalation in steps of 50 (regimen A) or 100 mg/m² (regimen B). In regimen A 5-FU dose reduction to 300 mg/m² due to toxicity was necessary in 49% of the patients; in regimen B a 5-FU dose of 600 mg/m² or above was tolerated by 70% of the patients. Dose-limiting toxicity was severe mucositis and/or diarrhea. Objective responses were observed in 5 of 33 patients (15%) in regimen A (3-28%, 95% confidence interval) and 7 of 41 patients (17%) in regimen B (5-29%, 95% confidence interval). Median time to progression was 4.7 and 4.8 months, and median survival 9.9 and 11.4 months for regimens A and B, respectively. Prolonged 5-FU administration over 2 h allows the administration of a higher 5-FU dose compared to bolus injection with no apparent improvement in antineoplastic efficacy. The addition of interferon to the combination of 5-FU plus FA in this dose and schedule does not seem to improve the response rate but appears to increase treatment toxicity.